Device Problems
Moisture Damage (1405); Structural Problem (2506)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The pump has been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging a casing/condition (case damage w/moisture) issue.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.
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Manufacturer Narrative
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The device has been returned and evaluated by product analysis on 09/23/2016 with the following findings: during investigation, moisture was found in the battery compartment.A leak test was performed and failed due to a crack in the battery compartment along the side.The pump was opened to find no moisture.
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Manufacturer Narrative
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Follow-up #2 date of submission 03/20/2017 - correction to serial #.
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Search Alerts/Recalls
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